Device product
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
Z-1246-2023
Product summary
- Event
- Event 91702
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1246-2023
Official wording
Reason: TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Code information: UDI-DI 10886982097033 Lot Number: 607P512
Distribution pattern: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
Derived failure modes
-
Unknown
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length